Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-31 @ 5:02 AM
Study NCT ID:
NCT01408368
Status:
COMPLETED
Last Update Posted:
2011-08-03
First Post:
2011-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subtotal Versus Total Thyroidectomy for Graves' Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D006042', 'term': 'Goiter'}, {'id': 'D006111', 'term': 'Graves Disease'}, {'id': 'D049970', 'term': 'Graves Ophthalmopathy'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D005094', 'term': 'Exophthalmos'}, {'id': 'D009916', 'term': 'Orbital Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D006980', 'term': 'Hyperthyroidism'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-02', 'studyFirstSubmitDate': '2011-08-02', 'studyFirstSubmitQcDate': '2011-08-02', 'lastUpdatePostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Long-term control of Graves' disease", 'timeFrame': 'up to 60 months postoperatively', 'description': "Recurrence rate of hyperthyroidism and change in Graves' ophthalmopathy"}], 'secondaryOutcomes': [{'measure': 'Morbidity rate', 'timeFrame': 'up to 12 months postoperatively', 'description': 'recurrent laryngeal nerve injury and hypoparathyroidism'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Graves' disease", 'total thyroidectomy', 'bilateral subtotal thyroidectomy', "Graves' ophthalmopathy", 'morbidity rate'], 'conditions': ['Thyroid', 'Goiter']}, 'referencesModule': {'references': [{'pmid': '20174803', 'type': 'BACKGROUND', 'citation': 'Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Cichon S, Nowak W. Five-year follow-up of a randomized clinical trial of total thyroidectomy versus Dunhill operation versus bilateral subtotal thyroidectomy for multinodular nontoxic goiter. World J Surg. 2010 Jun;34(6):1203-13. doi: 10.1007/s00268-010-0491-7.'}, {'pmid': '18327526', 'type': 'BACKGROUND', 'citation': "Stalberg P, Svensson A, Hessman O, Akerstrom G, Hellman P. Surgical treatment of Graves' disease: evidence-based approach. World J Surg. 2008 Jul;32(7):1269-77. doi: 10.1007/s00268-008-9497-9."}, {'pmid': '21190983', 'type': 'BACKGROUND', 'citation': "Bartalena L. The dilemma of how to manage Graves' hyperthyroidism in patients with associated orbitopathy. J Clin Endocrinol Metab. 2011 Mar;96(3):592-9. doi: 10.1210/jc.2010-2329. Epub 2010 Dec 29."}, {'pmid': '20033406', 'type': 'BACKGROUND', 'citation': "Wilhelm SM, McHenry CR. Total thyroidectomy is superior to subtotal thyroidectomy for management of Graves' disease in the United States. World J Surg. 2010 Jun;34(6):1261-4. doi: 10.1007/s00268-009-0337-3."}, {'pmid': '12028087', 'type': 'BACKGROUND', 'citation': "Barakate MS, Agarwal G, Reeve TS, Barraclough B, Robinson B, Delbridge LW. Total thyroidectomy is now the preferred option for the surgical management of Graves' disease. ANZ J Surg. 2002 May;72(5):321-4. doi: 10.1046/j.1445-2197.2002.02400.x."}, {'pmid': '15650802', 'type': 'BACKGROUND', 'citation': "Chi SY, Hsei KC, Sheen-Chen SM, Chou FF. A prospective randomized comparison of bilateral subtotal thyroidectomy versus unilateral total and contralateral subtotal thyroidectomy for graves' disease. World J Surg. 2005 Feb;29(2):160-3. doi: 10.1007/s00268-004-7529-7. Epub 2005 Jan 18."}, {'pmid': '11038198', 'type': 'BACKGROUND', 'citation': "Witte J, Goretzki PE, Dotzenrath C, Simon D, Felis P, Neubauer M, Roher HD. Surgery for Graves' disease: total versus subtotal thyroidectomy-results of a prospective randomized trial. World J Surg. 2000 Nov;24(11):1303-11. doi: 10.1007/s002680010216."}, {'pmid': '22287122', 'type': 'DERIVED', 'citation': "Barczynski M, Konturek A, Hubalewska-Dydejczyk A, Golkowski F, Nowak W. Randomized clinical trial of bilateral subtotal thyroidectomy versus total thyroidectomy for Graves' disease with a 5-year follow-up. Br J Surg. 2012 Apr;99(4):515-22. doi: 10.1002/bjs.8660. Epub 2012 Jan 27."}]}, 'descriptionModule': {'briefSummary': "The extent of thyroid resection in Graves' disease remains controversial. The aim of this study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total thyroidectomy in patients with Graves' ophthalmopathy.", 'detailedDescription': "Graves' disease was first described in 1835. It is an autoimmune disorder caused by antibodies which bind to thyroid-stimulating hormone (TSH) receptors on the thyroid cell membrane. The overt clinical manifestation of this disease is usually characterised by presence of hyperthyroidism, thyroid associated ophthalmopathy and thyroid dermopathy.\n\nTreatment alternatives of Graves' disease include antithyroid medication, radioiodine therapy or thyroidectomy. The antithyroid medication is often used as the initial treatment for patients with newly diagnosed Graves disease in much of the world including Europe, Japan and South America. However, the use of radioiodine is the most common first-line treatment modality in the United States. Thyroidectomy should be considered in special circumstances such as in children and young adults, pregnant women, in the setting of ophthalmopathy, in the presence of thyroid nodules or big goitre, particularly when compressive symptoms, or substernal thyroid extension is diagnosed, as well as in cases of failed hyperthyroidism remission after antithyroid medication in patients refusing possible radioiodine treatment.\n\nThe surgical management of Graves' disease remains controversial. Some authors support total thyroidectomy while others prefer various subtotal procedures. Most low-volume surgeons avoid performing total thyroidectomies for Graves' disease owing to the assumed higher complication rates. On the other hand, an increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indications for this procedure include not only high-risk thyroid cancer, but also Graves's disease and multinodular goiter. It has been shown that total thyroidectomy for Graves' disease lowers to almost zero the disease recurrence rate. However, other issues like unclear benefit for natural course of Graves' ophthalmopathy balanced against assumed higher risk of morbidity following more radical thyroid resections need to be clarified.\n\nWe hypothesized that total thyroidectomy is superior to bilateral subtotal thyroidectomy for long-term control of Graves' disease. The aim of this study was to evaluate long-term results of bilateral subtotal thyroidectomy versus total thyroidectomy in patients with mild and active Graves' ophthalmopathy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* planned thyroid surgery for clinically, biochemically and immunologically diagnosed Graves' disease in patients with mild active ophthalmopathy and the posterior aspects of both thyroid lobes appearing normal on ultrasound of the neck.\n\nExclusion Criteria:\n\n* previous thyroid or parathyroid surgery,\n* recurrent hyperthyroidism after radioiodine ablation,\n* history of Graves' disease longer than 24 months,\n* thyroid nodules within the posterior aspect/s of thyroid lobe/s,\n* suspicion of thyroid cancer,\n* inactive Graves' ophthalmopathy,\n* moderate to severe active Graves' ophthalmopathy,\n* preoperative recurrent laryngeal nerve palsy,\n* pregnancy or lactation,\n* age \\< 18 years, or \\> 65 years,\n* ASA 4 grade (American Society of Anaesthesiology),\n* inability to comply with the follow-up protocol."}, 'identificationModule': {'nctId': 'NCT01408368', 'briefTitle': "Subtotal Versus Total Thyroidectomy for Graves' Disease", 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': "Five-year Follow up of a Randomized Clinical Trial of Bilateral Subtotal Thyroidectomy Versus Total Thyroidectomy for Graves' Disease.", 'orgStudyIdInfo': {'id': 'BBN/501/ZKL/67/L'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bilateral subtotal thyroidectomy', 'interventionNames': ['Procedure: Bilateral subtotal thyroidectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Total thyroidectomy', 'interventionNames': ['Procedure: Total thyroidectomy']}], 'interventions': [{'name': 'Bilateral subtotal thyroidectomy', 'type': 'PROCEDURE', 'otherNames': ['BST'], 'description': 'The intervention consisted of bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each).', 'armGroupLabels': ['Bilateral subtotal thyroidectomy']}, {'name': 'Total thyroidectomy', 'type': 'PROCEDURE', 'otherNames': ['TT'], 'description': 'The intervention consisted of total extracapsular thyroidectomy.', 'armGroupLabels': ['Total thyroidectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31-202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Jagiellonian University, College of Medicine, Department of Endocrine Surgery, 3rd Chair of General Surgery', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Marcin Barczynski, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Piotr Laidler / Head of the Biomedical Research Committee of the Jagiellonian University', 'oldOrganization': 'Biomedical Research Committee of the Jagiellonian University'}}}}